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This is a three-period crossover phase I study designed to evaluate the relative bioavailability, food effect, safety and tolerability of SYHA1813 oral solution in healthy participants.
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-sequence ABC | Experimental | Participants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), followed by SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), and SYHA1813 oral solution (2.0g:25mg) fed (Treatment C). |
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| Group 2-sequence BCA | Experimental | Participants will sequentially receive SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), followed by SYHA1813 oral solution (2.0g:25mg) fed(Treatment C), and SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A). |
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| Group 3-sequence CAB | Experimental | Participants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fed (Treatment C), followed by SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), and SYHA1813 oral solution (20ml:200mg) fasted (Treatment B). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYHA1813 oral solution (2.0g:25mg) | Drug | SYHA1813 oral solution, 25mg, oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | Up to 120 hours post-dose for eachperiod |
| AUC0-∞ | Area under the plasma concentration time curve from time zero extrapolated to infinite time | Up to 120 hours post-dose for eachperiod |
| AUC0-t | Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration | Up to 120 hours post-dose for eachperiod |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time of maximum observed plasma concentration | Up to 120 hours post-dose for eachperiod |
| T1/2 | Terminal elimination half-life | Up to 120 hours post-dose for eachperiod |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology | Shanghai | China |
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3-period Crossover Assignment
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| SYHA1813 oral solution (20ml:200mg) | Drug | SYHA1813 oral solution, 25mg, oral |
|
| Title:Cl/F | Apparent total body clearance | Up to 120 hours post-dose for eachperiod |
| V/F | Apparent volume of distribution | Up to 120 hours post-dose for eachperiod |
| Number of participants with Adverse Events | Up to 34 days |